MOMETASONE FUROATE- mometasone furoate spray, metered

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MOMETASONE (UNII: 8HR4QJ6DW8) (MOMETASONE - UNII:8HR4QJ6DW8)

Available from:

REMEDYREPACK INC.

INN (International Name):

MOMETASONE

Composition:

MOMETASONE 50 ug

Administration route:

NASAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Mometasone Furoate Nasal Spray 50 mcg is indicated for the treatment of the nasal symptoms of seasonal allergic and perennial allergic rhinitis, in adults and pediatric patients 2 years of age and older. Mometasone Furoate Nasal Spray 50 mcg is indicated for the relief of nasal congestion associated with seasonal allergic rhinitis, in adults and pediatric patients 2 years of age and older. Mometasone Furoate Nasal Spray 50 mcg is indicated for the prophylaxis of the nasal symptoms of seasonal allergic rhinitis in adult and adolescent patients 12 years and older. Mometasone Furoate Nasal Spray 50 mcg is indicated for the treatment of nasal polyps in patients 18 years of age and older. Mometasone furoate nasal spray is contraindicated in patients with known hypersensitivity to mometasone furoate or any of its ingredients. Teratogenic Effects: Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Mometasone furoate nasal spray 50 mcg, like other corticosteroids, should be

Product summary:

Mometasone Furoate Nasal Spray, 50 mcg is supplied in a white, high-density, polyethylene bottle fitted with a white metered-dose, manual spray pump, and translucent cap. It contains 17 g of product formulation, 120 sprays, each delivering 50 mcg of mometasone furoate per actuation. (NDC 60505-0830-1). Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature]. Protect from light. When Mometasone Furoate Nasal Spray, 50 mcg is removed from its cardboard container, prolonged exposure of the product to direct light should be avoided. Brief exposure to light, as with normal use, is acceptable. SHAKE WELL BEFORE EACH USE. Keep out of reach of children.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MOMETASONE FUROATE- MOMETASONE FUROATE SPRAY, METERED
REMEDYREPACK INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MOMETASONE FUROATE NASAL SPRAY
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
MOMETASONE FUROATE NASAL SPRAY.
MOMETASONE FUROATE NASAL SPRAY 50 MCG
INITIAL U.S. APPROVAL: 1997
INDICATIONS AND USAGE
Mometasone Furoate Nasal Spray is a corticosteroid indicated for:
1. Treatment of Nasal Symptoms of Allergic Rhinitis in patients ≥2
years of age ( 1.1)
2. Treatment of Nasal Congestion Associated with Seasonal Allergic
Rhinitis in patients ≥2 years of age ( 1.2)
3. Prophylaxis of Seasonal Allergic Rhinitis in patients ≥12 years
of age ( 1.3)
4. Treatment of Nasal Polyps in patients ≥18 years of age ( 1.4)
DOSAGE AND ADMINISTRATION
For Intranasal Use Only
Treatment of Nasal Symptoms of Allergic Rhinitis ( 2.1)
Adults & Adolescents (12 yrs. and older): 2 sprays in each nostril
once daily
Children (2–11 yrs.): 1 spray in each nostril once daily
Treatment of Nasal Congestion Associated with Seasonal Allergic
Rhinitis ( 2.2)
Adults & Adolescents (12 yrs. and older): 2 sprays in each nostril
once daily
Children (2–11 yrs.): 1 spray in each nostril once daily
Prophylaxis of Seasonal Allergic Rhinitis ( 2.3)
Adults & Adolescents (12 yrs. and older): 2 sprays in each nostril
once daily
Treatment of Nasal Polyps ( 2.4)
Adults (18 yrs. and older): 2 sprays in each nostril twice daily. 2
sprays in each nostril once daily may also be effective in
some patients.
DOSAGE FORMS AND STRENGTHS
Nasal Spray: 50 mcg of mometasone furoate in each 100-microliter spray
( 3)
CONTRAINDICATIONS
Patients with known hypersensitivity to mometasone furoate or any of
the ingredients of mometasone furoate nasal spray.
( 4)
WARNINGS AND PRECAUTIONS
Epistaxis, nasal ulceration, _Candida albicans_ infection, nasal
septal perforation, impaired wound healing. Monitor
patients periodically for signs of adverse effects on the nasal
mucosa. Avoid use